Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
CIPS
1 other identifier
interventional
182
0 countries
N/A
Brief Summary
To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 13, 2017
July 1, 2017
1.2 years
July 11, 2017
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of digestive system complications after operation
The incidence of digestive system complications within one week after surgery
12 hours to one week after surgery
The concentration of intestinal fatty acid-binding protein (I-FABP)
The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation
12 h after operation
Secondary Outcomes (1)
Postoperative heart and respiratory complications within one week
12 hours to one week after surgery
Study Arms (2)
control group
NO INTERVENTIONTourniquet would be tied to left upper limb of Patients who undergoing laparotomy for 30 minutes after the induction of anesthesia,but put no press on it. Other processes are consistent with conventional methods.
intervention
EXPERIMENTAL1. After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning. 2. At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure. 3. Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.
Interventions
After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.
At the beginning of anesthesia induction, 3 ug/kg/h of dexmedetomidine was infused and adjusted to 0.3 ug/kg/h after 10 min of infusion until 30 minutes before the end of the procedure.
Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min.
Eligibility Criteria
You may qualify if:
- Aged between 18 and 70 years;
- Elective abdominal surgery under general anesthesia, operation time \> 2h;
- ASA Ⅰ \~ Ⅲ;
- Patient informed and consent to accept the test.
You may not qualify if:
- persons under the age of 18 or over 70 years old;
- pregnant or lactating women;
- combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
- preoperative Hb \<7g / l;
- oral sulfa drugs or nicorandil antihypertensive drugs;
- lower extremity amputees;
- with peripheral vascular disease;
- patients with mental illness or severe neurosis;
- can not express the subjective symptoms;
- nearly 3 months to participate in other drug clinical trials;
- within 3 months of receiving other surgical treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
PMID: 20484066BACKGROUNDHausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PMID: 17707752RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ke-Xuan Liu, Ph.D
Nanfang Hospital, the Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Anesthesiology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
August 1, 2017
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
July 13, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share